Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
The main goal of this phase II study is to evaluate the overall response rate of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. The study drugs provided for research purposes are isatuximab and belantamab mafodotin.
Eligibility criteria
Qualifiers
Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).
Age ≥ 18 years
Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval
Disqualifiers
Participant must not have had current corneal epithelial disease except mild changes in corneal epithelium.
Participant must not use contact lenses while participating in this study.
Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
Participants who are receiving any investigational agents.
Trial design
Treatments tested in this trial
- Isatuximab
- Belantamab mafodotin
- Pomalidomide
- Dexamethasone
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov